EC proposals for strengthening pharmacovigelance to reduce drug ADRs

Medicinal products contribute considerably to the health of European Union citizens. They can, however, also have adverse effects. It is  estimated that 5% of all hospital admissions are due to an adverse drug  reaction and that ADRs are the fifth most common cause of hospital  death. In light of experience, and following an assessment of the EU  pharmacovigilance system (supervision and monitoring of ADRs) by the  European Commission, officials say it has become clear that new  measures are necessary to improve how the EU rules operate on the  pharmacovigilance of medicinal products.

As a result, the Commission has issued proposals seeking to change the  existing EU legislation on pharmacovigilance (provisions in Regulation  (EC) No 726/ 2004 and Directive 2001/83/EC). They aim to strengthen and  rationalize the system, with the overall objectives of better  protecting public health, ensuring proper functioning of the internal  market and simplifying the current procedures.

Some adverse reactions can only be detected after a drug has been  authorized. The full safety profile of medicines can only be known once  they have entered the market. The supervision and monitoring of adverse  reactions of cleared products are carried out through the EU's  pharmacovigilance system. This ensures that any product, which presents  an unacceptable level of risk can be rapidly withdrawn from the market.  Thus pharmacovigilance comprises collecting and managing data on the  safety of medicines, evaluating this and deciding to act to protect  public health. It is estimated that 197,000 deaths a year in the EU are  caused by ADRs and that the total cost to society of these in the EU is  79.0 billion euros ($108.0 billion). These proposals are aimed at  further improving the current system. They will save many lives per year  across the EU. In addition, they will help to cut red tape by decreasing  the administrative burden by about 145.0 billion euros a year.